TECARTUS Dispersion for infusion Ref.[49724] Active ingredients: Brexucabtagene autoleucel

Tecartus (brexucabtagene autoleucel) is a genetically modified autologous cell-based product containing T cells transduced ex vivo using a retroviral vector expressing an anti-CD19 chimeric antigen receptor (CAR) comprising a murine anti-CD19 single chain variable fragment (scFv) linked to CD28 co-stimulatory domain and CD3-zeta signalling domain.

Mantle cell lymphoma

Each patient-specific infusion bag of Tecartus contains brexucabtagene autoleucel at a batchdependent concentration of autologous T cells genetically modified to express an anti-CD19 chimeric antigen receptor (CAR-positive viable T cells). The medicinal product is packaged in one infusion bag overall containing a cell dispersion for infusion of a target dose of 2 × 10⁶ anti-CD19 CAR-positive viable T cells/kg body weight (range: 1 × 10⁶ – 2 × 10⁶ cells/kg), with a maximum of 2 × 10⁸ anti-CD19 CAR-positive viable T cells suspended in a Cryostor CS10 solution.

Each infusion bag contains approximately 68 mL of dispersion for infusion.

Acute lymphoblastic leukaemia

Each patient-specific infusion bag of Tecartus contains brexucabtagene autoleucel at a batchdependent concentration of autologous T cells genetically modified to express an anti CD19 chimeric antigen receptor (CAR-positive viable T cells). The medicinal product is packaged in one infusion bag overall containing a cell dispersion for infusion of a target dose of 1 × 10⁶ anti CD19 CAR positive viable T cells/kg body weight, with a maximum of 1 × 10⁸ anti CD19 CAR positive viable T cells suspended in a Cryostor CS10 solution.

Each infusion bag contains approximately 68 mL of dispersion for infusion.

Excipient(s) with known effect:

This medicinal product contains 300 mg sodium.

Each dose contains 0.05 mL of dimethyl sulfoxide (DMSO) per mL of Tecartus.

For the full list of excipients, see section 6.1.